MAUDE Adverse Event Report: SYNTHES TUTTLINGEN DISC RONGEUR STRAIGHT WITHOUT TEETH 4MM WIDTH 330MM

Catalog Number 03.605.001

Device Problem Unstable (1667)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

It was reported that the following part/lot number: 03.802.431/8255956 and part/lot number: 03.802.43/12712317 (both are u-joint drivers) have lost their positional memory.In addition, part 03.605.001 lot number t938638 has been reported that a screw loosened and fell out of the superior arm of the kerrison preventing it from closing the tips of the instrument.No patient involvement nor a time delay reported for this complaint.Complaint involves 3 devices.

Manufacturer Narrative

Device is used for treatment, not diagnosis.Device is an instrument and is not implanted/explanted.Review of the device history record showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.No nonconformance reports were generated during production.Subject device has been received and is currently in the evaluation process.Investigation is ongoing; no conclusion could be drawn.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional narrative: an evaluation was performed on the returned device.As per received condition of device; the screw holding the upper slide fell off and was not received.The manufacturing evaluation shows that there were no issues during the manufacture of the product that would contribute to this complaint condition.There is a little indentation near to the screw which confirms that the screw was secured with a laser point.The root cause is; too much force causing the screw to fell off.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: DISC RONGEUR STRAIGHT WITHOUT TEETH 4MM WIDTH 330MM
• Type of Device: RONGEUR
• Manufacturer (Section D): SYNTHES TUTTLINGEN; unter hasslen 5; tuttlingen 7853 2; GM 78532
• Manufacturer (Section G): SYNTHES TUTTLINGEN; unter hasslen 5; tuttlingen 7853 2; GM 78532
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4484856
• MDR Text Key: 5503933
• Report Number: 9680938-2015-10018
• Device Sequence Number: 1
• Product Code: HTX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 01/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.605.001
• Device Lot Number: T938638
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/27/2015
• Initial Date FDA Received: 02/04/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/05/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/20/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1